PlainHospital
2026 data FDA MAUDE openFDA FDA Class III

Aortic Valve, Prosthesis, Percutaneously Delivered

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Aortic Valve MID-BOOK · MAUDE

#50 of 1000 · 78,144 reports · 2004–2026

  • BOOK 78,144 reports
  • RANK #50 of 1000
  • DEATH 7,956 death-typed
  • INJ 58,351 injury-typed
  • MALF 11,821 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 13,120
  • PHOTO Colonoscope And Acces…

Nearest event-volume peer: Colonoscope And Accessories, Flexible/Rigid (154 report gap)

Aortic Valve, Prosthesis, Percutaneously Delivered sits #50 of 1000 among tracked device types with 78,144 MAUDE reports spanning 2004–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

Aortic Valve carries 15.1% MALFUNCTION-coded reports, 49.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 10.2% corpus 1.5% · above corpus mean (+8.7 pp)
  • INJ 74.7% corpus 30.3% · above corpus mean (+44.4 pp)
  • MALF 15.1% corpus 64.8% · below corpus mean (-49.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 30% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 43% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Aortic Valve in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Aortic Valve, Prosthesis, Percutaneously Delivered carries 78,144 MAUDE reports, ranked #50 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 58,351 (74.7%)
Malfunction 11,821 (15.1%)
Death 7,956 (10.2%)
12 (0.0%)
Other 4 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 47,539 (52.6%)
10,728 (11.9%)
Death 6,848 (7.6%)
R 6,414 (7.1%)
Life Threatening 3,873 (4.3%)
Hospitalization 3,309 (3.7%)
H 2,956 (3.3%)
Other 2,949 (3.3%)
L 2,788 (3.1%)
D 1,145 (1.3%)
Disability 865 (1.0%)
S 618 (0.7%)
O 282 (0.3%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 27,471
Perivalvular Leak 10,158
Patient Device Interaction Problem 9,217
Insufficient Device Problem Information 7,936
Device Dislodged or Dislocated 6,578
Malposition of Device 3,933
Gradient Increase 2,458
Material Invagination 2,359
Degraded 2,335
Intravalvular regurgitation 2,284
Device Stenosis 2,206
Burst Container or Vessel 2,192
Calcified 2,166
Fluid/Blood Leak 2,126
Activation Failure 2,047
Migration or Expulsion of Device 1,840
Difficult to Remove 1,767
Difficult or Delayed Positioning 1,546
Material Deformation 1,266
Material Split, Cut or Torn 983

Yearly Trend

04
2004: 1
12
2012: 98
13
2013: 1,096
14
2014: 2,161
15
2015: 2,862
16
2016: 2,995
17
2017: 3,115
18
2018: 3,916
19
2019: 4,361
20
2020: 5,806
21
2021: 5,604
22
2022: 5,994
23
2023: 8,319
24
2024: 11,043
25
2025: 13,120
26
2026: 7,653

Reports in 2025 (13,120) held close to the prior two-year average of 9,681.

Related Entities for Aortic Valve, Prosthesis, Percutaneously Delivered

Top Manufacturers

EDWARDS LIFESCIENCES 32,964
MEDTRONIC HEART VALVES DIVISION 28,310
MEDTRONIC MEXICO S. DE R.L. DE CV 5,156
ABBOTT MEDICAL 4,585
EDWARDS LIFESCIENCES LLC 3,628
BOSTON SCIENTIFIC CORPORATION 1,231
MEDTRONIC IRELAND 1,085
Medtronic Mexico S. De R.L. De CV 234
Edwards Lifesciences 118

Event Locations

51,462 (65.9%)
I 26,520 (33.9%)
HOSPITAL 85 (0.1%)
NO INFORMATION 75 (0.1%)
OTHER 2 (0.0%)

Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Aortic Valve: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (78,144 here).

Colonoscope And Accessories, Flexible/Rigid 78,298 Analyzer, Chemistry, For Clinical Use 78,872 Intraocular Lens 79,358 Orthopedic Manual Surgical Instrument 81,214

Similar death-typed counts

Nearest other device types by death-typed report count (7,956 here), distinct from the volume row.

System 7,074 Permanent Pacemaker Electrode 9,381 Implantable Cardioverter Defibrillator 10,094 Temporary Non-Roller Type Left Heart Suppor… 5,667

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Aortic Valve are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Aortic Valve; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.